Details for New Drug Application (NDA): 209224
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The generic ingredient in LACOSAMIDE is lacosamide. There are twenty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the lacosamide profile page.
Summary for 209224
Tradename: | LACOSAMIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | lacosamide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209224
Physiological Effect | Decreased Central Nervous System Disorganized Electrical Activity |
Suppliers and Packaging for NDA: 209224
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LACOSAMIDE | lacosamide | SOLUTION;ORAL | 209224 | ANDA | Aurobindo Pharma Limited | 59651-016 | 59651-016-02 | 200 mL in 1 BOTTLE, PLASTIC (59651-016-02) |
LACOSAMIDE | lacosamide | SOLUTION;ORAL | 209224 | ANDA | Aurobindo Pharma Limited | 59651-016 | 59651-016-46 | 465 mL in 1 BOTTLE, PLASTIC (59651-016-46) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 10MG/ML | ||||
Approval Date: | Jan 24, 2024 | TE: | AA | RLD: | No |
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